Ibrutinib's Breakthrough to Market

FDA’s new Breakthrough Therapies designation sped Pharmacyclics/J&J’s ibrutinib (brand name: Imbruvica) through regulatory review in four months, based on Phase 2 studies. Pricing and access issues, though, may not get resolved so quickly.

On a conference call with investors on the day FDA approved Imbruvica (ibrutinib), a Breakthrough Therapy-designated treatment for Mantle Cell Lymphoma (MCL), Robert Duggan, CEO at Pharmacyclics, praised the FDA for its “vision, leadership and execution.” That praise is understandable, considering that Imbruvica went from first-in-man trials to commercial availability in just four and a half years.

Imbruvica was approved on the basis of phase 2 studies, and biotech analysts were pleased to note that FDA greenlighted the drug just four months after the NDA submission was filed – a two-month improvement over the standard six-month accelerated approval period – ostensibly thanks to Imbruvica’s Breakthrough status.

Roughly 150 sales reps (half Janssen, half Pharmacyclics) will market Imbruvica, targeting around 7,000 of the 8,000 hematologist/oncologists practicing in the US. The drug was made available on the day it was approved, company executives said on the call.

Currently indicated in the refractory setting, Imbruvica costs $91.11 per pill, or just under $11,000 a month ($132,000 annually) for MCL patients taking four pills a day. If approved for CLL, that cost will drop to roughly $8,200 a month, since CLL patients would take only three pills a day. This is a premium price per pill, to be sure, but it’s more or less in line with its competitors in these small (CLL) and smaller (MCL) Non-Hodgkins lymphoma cancer subtypes. According to Kantar Health data, the 2013 total drug-treated MCL population in the US is 4,747 patients; in CLL, that number is 15,415.

Imbruvica’s average duration of response extends to 18 months; that’s a lot of pills, and a lot of coverage changes for Medicare Part D patients. Responding to a question about the anticipated payer mix for Imbruvica during the Pharmacyclics conference call, Matt Outten, senior director of market access, said the company anticipates a “higher percentage” of Medicare Part D patients, meaning more than half of US sales will depend on whether or not patients can afford the leftover costs of what the government, and pharma, won’t pay.

Debbie Warner, VP, commercial planning at Kantar Health (and formerly a managed markets oncology brand director at AstraZeneca), says patients just starting out with a Medicare benefit and hoping to access Imbruvica could pay roughly $2,657 out of pocket from treatment initiation through the end of the donut hole, followed by a monthly payment of around $650 (or five percent of the drug cost under Medicare Part D’s catastrophic coverage) after that: until the end of the calendar year, when the whole process resets.

Imbruvica isn’t listed yet on the Medicare.gov website, but the $2,656 figure Warner cites is based on an examination of Celgene’s Revlimid, which picked up an indication for MCL patients in June and is priced at almost $13,000 for a month supply, according to Kantar. Revlimid has an average 16.6 month duration of response in MCL, according to the PI. Below is Kantar’s breakdown for Revlimid coverage under Medicare Part D, with an AARP Medicare Rx Saver plus plan. ICL stands for Initial Coverage Limit, and OOP stands for Out of Pocket:

The true out of pocket cost for a Medicare patient taking Imbruvica could be $2,656, plus a $650 monthly payment during the catastrophic coverage period, according to Medicare rules and Kantar’s analysis, but Warner cautions that the amount could vary. “I can’t say definitively what Imbruvica will cost Medicare patients before it is actually loaded into Medicare’s formulary finder,” says Warner. “Each plan may have slightly different pharmacy reimbursement rates, which would cause the co-pay during catastrophic coverage to vary somewhat.”

Given the small patient population for MCL, it’s likely that many will receive financial help from foundations and other third party organizations. On the Pharmacyclics call, Outten said “a majority of MCL patients will qualify for at least one of our [financial assistance] programs.”

Pharmacyclics “You&i” program offers eligible patients up to 60 days of free Imbruvica therapy, in an effort to overcome insurance coverage and reimbursement delays and other hang-ups. Pharmacyclics executives said they would not seek retroactive reimbursement from payers for patients receiving free Imbruvica during this period.

A second You&i program, called Access Instant Savings, helps commercially insured patients who “find it difficult” to pay the copay or coinsurance out-of-pocket expense afford the drug, said Outten. “These patients will receive support so that they have a maximum monthly out of pocket expense of $25,” said Outten. That $25 copay cap for commercially insured patients will continue throughout the course of treatment, or up to 19% of the drug’s full wholesale acquisition cost, per patient, he said.

Janssen/J&J will help uninsured low-income patients (those who make less than 600% of the federal poverty limit) get access to Imbruvica.

Will foundations and non-profits pick up the tab for Medicare patients with co-pays likely to exceed – significantly – the $25 monthly cap for commercially insured patients? The answer to that question is an important one for elderly, fixed-income MCL patients, and Pharmacyclics/J&J alike